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Strategic Advisor Support

Strategic Advisor Area of Expertise
Jennifer DiGiacinto, PharmD
Dr. DiGiacinto has over 13 years of extensive experience in the Biopharmaceutics, Clinical Pharmacology, and Regulatory Affairs arenas which commenced at the Office of Clinical Pharmacology at the US Food and Drug Administration (FDA) assigned to the Division of Antiretroviral Products (DAVP). After 7 years at FDA, she joined Salamandra, LLC, and provided technical and regulatory advice relating to Phase 1 and Phase 2A drug development stages. Areas of expertise include early clinical study design development, eg, BA/BE, F-E, DDI (one-way, bi-directional, and cocktail), SD, MD, SAD, MAD, FIM, Ethnobridging, PK/PD, Special Populations [renal and hepatic impairment], pediatrics, dose proportionality, dissolution, etc; in vitro metabolism and transporter studies (inhibition and induction); Contract Research Organization (CRO) selection and/or vetting; study management, which includes but is not limited to, protocol development, data analysis, and study report generation across multi-therapeutic areas; and assisting clients with FDA meeting preparation and attendance at meetings. Recent work has been in Alzheimer’s disease, endocrinology, infectious disease, asthma (inhalation products), pain (abuse-deterrent opioids), oncology, gastro-intestinal, virology (HIV, HCV, HSV1, and HSV2), and dermatologic products. Within the last 6 years Dr. DiGiacinto has worked on multi therapeutic programs that were submitted across multiple CDER Divisions. She has also been involved with due diligence activities for clients and Venture Capital companies. ×
Clinical Pharmacology
Catharine Dorrier, MS
Catharine Dorrier is a Senior Technical Advisor at RRD International, LLC. She has over 35 years of experience in the field of clinical trial design, conduct of clinical trials, and analysis and reporting of results. She has provided senior oversight to domestic and global development programs for product approval. Her focus is the effective design, management and evaluation of trials to conform to FDA regulatory requirements and to support approvable regulatory submissions. Prior to working with RRD, she worked with Quintiles, Inc. and BRI International as vice president of clinical operations and senior program director. She has experience with both pharmaceutical and medical device research. Ms. Dorrier graduated from University of North Carolina and received a master’s degree in biostatistics and epidemiology from Georgetown University. ×
Clinical Trial Design & Analysis
P. Michael Dubinsky
Michael is an independent consultant providing expert guidance to clients in GXP compliance. Mike’s experience includes 24 years with the FDA where he performed or managed compliance and enforcement work for the Centers for Biologics, Drugs and Medical Devices. His experience while at the FDA spanned GMP, GLP and GCP activities. Mike held the position of Deputy Director, Office of Compliance, CBER when he left FDA in 1998. While employed in the pharmaceutical / biotech industry from 1998 through 2006 Mike held senior level positions in Regulatory Affairs, Quality Assurance, Development Quality Assurance and Compliance. In the time period 2007-2013 Mike’s focus has been consulting and serving as an instructor for the University of California Berkeley Extension program in topics related to the conduct of clinical trials. ×
GxP Compliance
Jeffrey Gelb, MD
Jeffrey Gelb, MD is a consultant to RRD International, LLC in the role of Strategic Advisor focusing on global product development and medical affairs. Dr Gelb is a physician with more than 20 years of global drug development and medical affairs experience in biotech, pharma, and CRO settings. Dr Gelb has broad industry expertise with emphasis on advancing specialty medicines through development globally. He has successfully led global BLA/NDA, MAA, IND filings, REMS/RMP programs, development and lifecycle strategies, and FDA advisory committees. Dr Gelb has worked at the VP level at Shire, NPS Pharma, Covance, and Bristol-Myers Squibb including biologics and small molecule programs in rare diseases, immunology, renal, GI, and cardiovascular. Previously, he led a clinical program team at Ortho Biotech within Johnson & Johnson. Dr Gelb earned his MD degree from the University of Pennsylvania and his Bachelor of Science (BS) degree in Biology and Classical Studies from Tufts University. ×
Immunology/GI/Rare Diseases
William Kramer, PhD
As a drug development consultant, William G. Kramer, Ph.D., draws on his over 30 years of experience in the pharmaceutical industry and academic research to work with client companies in the development of research strategies to minimize the time for completion of clinical trials and FDA approval. An expert in clinical pharmacology, pharmacokinetics and pharmacodynamics, Dr. Kramer assists client companies in program design, protocol preparation, study implementation, and the analysis and interpretation of results. Dr. Kramer has prepared pharmacokinetic sections of INDs, NDAs, ANDAs, BLAs, and submissions to European regulatory agencies. He has presented at all levels of FDA meetings, including Advisory Committee Meetings, and has published extensively on the pharmacokinetics/dynamics of drugs in adult and pediatric populations.
Prior to forming Kramer Consulting LLC, Dr. Kramer was a Senior Consultant at Quintiles Consulting and before that served as Director, Clinical Research, and Head, Pharmacokinetics and Bioanalytics, at Boehringer Mannheim where he created and maintained the pharmacokinetic plan for all drug projects in the U.S. Other positions in which Dr. Kramer worked include serving in the Department of Drug Metabolism and Pharmacokinetics at Schering-Plough Corporation, and he spent ten years teaching and conducting clinical pharmacokinetic research at the University of Houston College of Pharmacy.
Dr. Kramer received a Ph.D. in Pharmaceutics at Ohio State University, Columbus, OH, and a B.S. in Pharmacy from the University of Pittsburgh, PA. ×
Pharmacokinetics
Ian Krane, PhD
Dr. Krane has more than 20 years of experience at the bench in basic research and drug development, from reproductive biology to gene expression and breast cancer. Prior to joining RRD, he was a Senior Scientist at GTC Biotechnology, Inc., a company using transgenic technology as a platform for the production of biologics in the milk of goats and other animals. Dr. Krane received a PhD in Cell and Developmental Biology from the Division of Medical Sciences at Harvard University (Cambridge, MA) and he was a Postdoctoral Fellow in the Department of Genetics at Harvard Medical School where he was among the first recipients of a grant from the Massachusetts Breast Cancer Initiative as well as a Department of Defense Breast Cancer Research Award. ×
Protein Expression and Molecular Biology
Maryann Krane
Maryann Krane is a Senior Technical Advisor at RRD International, LLC. Ms. Krane joined RRD from Ariad Pharmaceuticals, Inc. where she was Vice President of Regulatory Affairs and Corporate Quality. Previously, Ms. Krane held management level positions at several biotechnology companies, including Genetics Institute and Wyeth Pharmaceuticals. Ms. Krane has broad drug development experience in multiple therapeutic areas including hematology/oncology, neurology, endocrinology, pulmonary, special pathogens, and gene therapy. She has developed successful global product registration strategies for several hematology and oncology products and has extensive submission experience developing IND, BLA, MAA, NDA, NDS, Orphan Designation, Fast Track, Special Protocol Assistance, and European Scientific Advice applications. Ms. Krane holds a BS in Microbiology from the University of Massachusetts. ×
Regulatory Affairs
Carolyn Pratt
Ms. Pratt is an Affiliate of RRD International, LLC (RRD). From 2002-2012 Ms. Pratt served as Founding Member and Executive Vice President at RRD. Ms. Pratt joined RRD after spending five years as an equity analyst covering the biotechnology sector at Needham & Co. and Montgomery Securities. Prior to that, Ms. Pratt was at Genetics Institute for seven years, where she worked as Manager of Business Development and as Product Manager for a novel protein therapeutic, BMP-2. She began her professional career with the Ortho Pharmaceuticals division of Johnson & Johnson, where she worked in clinical research and also in the development and commercial launch of the first FDA-approved therapeutic monoclonal antibody, Orthoclone OKT3. Ms. Pratt holds a degree in Pharmacy. ×
Development Strategy
Laura Redden, MD, PhD
Dr. Redden is a consultant to RRD International, LLC in the role of Strategic Advisor focusing on global product development and registration programs, medical affairs, and clinical pharmacology. Dr. Redden is a physician/scientist with solid working experience across various therapeutic areas including but not limited to clinical pharmacology, neuroscience, immunology/rheumatology, and medical devices. She has twenty years of clinical research and development experience in both academic and industry settings. Her experience spans from early phase development to post-marketing (Phases I-IV, including filing of INDs, NDAs, and BLAs). Dr. Redden has held several global executive and managerial positions including Project Director/Global Project Head of the Humira® rheumatology and device teams at Abbott Laboratories, Vice president of Medical Services at Advanced Clinical, LLC, and Executive Medical Director/Clinical Science Head of the Immunology team at Takeda Pharmaceuticals. Dr. Redden received her medical degree from the University of Guadalajara in Mexico, and her doctoral degree in Clinical Pharmacology from the University of Toronto, Canada. ×
Neuroscience/Immunology
Eric Rowinsky, MD
Eric K. Rowinsky, MD, is principally focused on the comprehensive development and registration strategies of cancer therapeutics of all types. Dr. Rowinsky received his B.A. degree from New York University and his M.D. from the Vanderbilt University School of Medicine. Following his residency in internal medicine at the University of California, he completed fellowship training in medical oncology and clinical pharmacology at the Johns Hopkins University School of Medicine. From 1987 to 1996, Dr. Rowinsky served as an Associate Professor of Oncology at the Johns Hopkins University School of Medicine where he performed seminal clinical development and pharmacologic studies on paclitaxel, docetaxel, irinotecan, topotecan, among other agents. From 1996-2004, he served as the Director of Clinical Research and later Director of the Institute for Drug Development of the Cancer Therapy and Research Center in San Antonio where he held the SBC Endowed Chair for Early Drug Development from 1996-2005 and was a lead investigator on early developmental studies of many classes of targeted therapeutics such as erlotinib, gefitinib, panitumumab, temsirolimus, ridaforolimus, trabectedin, and many other agents. He was also Clinical Professor of Medicine in the Division of Medical Oncology at the University of Texas Health Science Center at San Antonio from 1996-2006. From 2005-2007, Dr. Rowinsky served as the Chief Medical Officer and Senior Vice President at ImClone Systems, responsible for clinical development and regulatory affairs at ImClone Systems. From 2007-2009, he was an Executive Vice President of ImClone Systems, which became a wholly-owned subsidiary of Eli Lilly after its acquisition. In 2012, Dr. Rowinsky joined Stemline Therapeutics as the Head of Research and Development, Executive Vice President, and Chief Medical Officer. He is also an Adjuvant Professor of Medicine at New York University School of Medicine. Prior to joining ImClone in 2005, Dr. Rowinsky was a longstanding NCI principal investigator on U01 anticancer drug development grants and integrally involved in pivotal clinical and preclinical investigations which lead to the development of both classical chemotherapeutics and targeted therapies including a wide variety of cytotoxic and targeted anticancer therapeutics.
Dr. Rowinsky is the Editor-in-Chief of Investigational New Drugs, an Associate Editor and Editorial Board Member of Cancer Research (Associate Editor and Reviews Editor), Clinical Cancer Research, Annals of Oncology, Cancer Biology and Therapy and several other oncology journals and has published approximately 300 manuscripts in both the preclinical and clinical research fields. He has also served on the Board of Directors, Scientific Advisory Board and Project Advisory Boards of a large number of pharmaceutical and biotechnology companies and has advised and/or presented aspects of New Drug Applications to the FDA on several occasions. Dr. Rowinsky’s honors include receipt of the career development award of the American Cancer Society and the 6th Annual Emil J. Freireich Award for outstanding achievement of a young researcher in clinical cancer therapeutics. He has also served on the Board of Scientific Counselors of the NCI. Dr. Rowinsky is on the board of directors of several public companies including Biogen Idec Inc., Navidea Inc, and Coronado Biosciences Inc. ×
Oncology
David West, PhD, MPH
Founder and Principal
Device Development and Regulatory Consulting, LLC (DDRC)
Since 1994, Dr. West has served as a senior advisor to medical device companies in their development and regulation of novel medical devices and device / drug / biologic combination products. Prior to the formation of DDRC, from 1994 to 2013 Dr. West served principally as Vice President, Medical Device Development, at Quintiles.
He has assisted domestic and international medical device companies develop and implement strategic and regulatory plans for medical devices and combination products. Dr. West has been providing clients strategic and regulatory guidance and support throughout the product development and regulatory approval processes, identifying and reviewing both non-clinical and clinical studies and offering expert assistance in the preparation of Premarket Approval (PMA), Investigational Device Exemptions (IDE), Product Development Protocol (PDP), Premarket Notification [510(k)], De Novo, Section 513(g), and Request for Designation (RFD) submissions to the Food and Drug Administration (FDA), as well as helping management of company communications and interactions with. Dr. West offers clients the benefit of 26 years of service as a commissioned officer in the U.S. Public Health Service, including 11 years in senior management positions at FDA.
From 1989 to 1993 Dr. West was Deputy Director of Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH), FDA. From 1985 to 1989, he was Associate Director, ODE. In these two positions he was responsible for planning, managing and directing programs to ensure the safety and effectiveness of medical devices, including extensive review of IDE, PMA and 510(k) applications. During his tenure in these two positions, he exercised final FDA review and signature authority of for virtually all IDE and PMA applications, and for precedent-setting, complex or potentially controversial 510(k)s. Dr. West was a principal architect of the decision framework for FDA's evaluation and regulation of combination products of medical devices, drugs, and/or biologics and served on FDA’s first Combination Products Task Force. Dr. West earned his PhD in Environmental Health (major) and Epidemiology (minor) at the University of Minnesota; his MPH at the School of Public Health, University of Minnesota; and his BS in Mechanical Engineering at the University of California, Santa Barbara. ×
Medical Devices
Gary Wolfe, PhD, DABT
Gary W, Wolfe, PhD, DABT is a consultant to RRD International, LLC in the role of Strategic Advisor focusing on pharmacology/toxicology. Dr. Wolfe received his MS in 1976 and PhD in 1978 from Purdue University in Pharmacology and Toxicology. He joined Hazleton Labs (now Covance) that year and served as a study director and later as Director of Toxicology. After that he worked at R.O.W. Sciences and TherImmune Laboratories (became GeneLogic Labs) where he served as study director and then as Senior Vice President and Chief Scientific Officer.
He also served as the Principal Investigator for the National Toxicology Program’s General Toxicology and Reproductive Assessment by Continuous Breeding Programs for over 15 years. After leaving GeneLogic Labs, he served as a consultant at Summit Drug Development and Aclairo Pharmaceutical Development Group providing scientific and regulatory advice to companies developing pharmaceutical products in the US, Europe, and Australia.
During the last six years, Dr. Wolfe has been an independent consultant involved in designing drug development programs and outsourcing nonclinical studies at various domestic and international contract research laboratories. He is a board certified toxicologist and member of the Society of Toxicology, the American College of Toxicology and the Teratology Society. ×
Toxicology
Kathryn Zunich, MD
Dr. Zunich is a board certified physician in Internal Medicine with subspecialty training in Allergy and Immunology. She has over 20 years’ experience in the pharmaceutical industry and more than 27 years’ overall experience in clinical trials and drug development. She assists clients in the strategic planning and implementation of development programs with an emphasis on clinical and regulatory support. Dr. Zunich is a founding member of Iasis Partners, LLC, a drug development consultancy.
Prior to founding Iasis Partners, Dr. Zunich was an independent medical consultant to the pharmaceutical industry and has also held senior positions at Syntex Research in Palo Alto, California and Univax Biologics in Rockville, Maryland. During that time, she played significant leadership roles in five successful NDAs, having key roles in the development of drugs such as mycophenolate mofetil (CellCept) for the prevention of acute rejection in solid organ transplantation, and biologics such as anti-Rho(D) (WinRho) for the treatment of immune thrombocytopenia. She has also made major contributions to the strategic planning and implementation of numerous INDs. Prior to joining industry, Dr. Zunich served as a Program Officer at the National Institute of Allergy and Infectious Diseases of the National Institutes of Health in Bethesda, Maryland, where she conducted clinical trials in HIV infection and associated complications. She also served as NIAID Section Chief in Transplantation and in Asthma, during which time she oversaw a portfolio of grants in allergy, immunology, and transplantation.
Dr. Zunich received her B.A. in Natural Science from Fordham University, her M.D. degree from Upstate Medical University of the State University of New York at Syracuse, and her internship and residency training in Internal Medicine and Primary Care at St. Vincent’s Hospital and Medical Center of New York. She subsequently completed a post-doctoral fellowship in Allergy and Immunology at National Jewish Health (formerly National Jewish Center for Immunology and Respiratory Medicine) in Denver, Colorado where she began her early work as an investigator in clinical trials and drug development. She is author or co-author of a number of peer-reviewed publications including original research and review articles. ×
Allergy and Immunology